
Asuragen, Inc.
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Quantidex qPCR BCR-ABL IS Kit is an FDA 510(k)-cleared medical device (DEN160003) manufactured by Asuragen, Inc.. This device is classified under the Medical Genetics specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2016. Regulation: 8.